MASULTAB 100 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: information for the user
2. Masultab, 50 mg, tablets
3. Masultab, 100 mg, tablets
4. Masultab, 200 mg, tablets
5. Masultab, 400 mg, tablets
   1. Table of contents of the leaflet
6. What is Masultab and what is it used for
7. Important information before taking Masultab
   1. When not to take Masultab:
   2. Warnings and precautions
   3. Masultab and other medicines
   4. The following medicines must not be taken at the same time as Masultab:
   5. The doctor will carefully monitor the use of Masultab in the case of concurrent use of the following medicines:
   6. Masultab and alcohol
   7. Pregnancy and breastfeeding
   8. Driving and operating machinery
   9. Masultab contains lactose and sodium
8. How to take Masultab
   1. Adolescents from 14 to 18 years old
   2. Elderly patients (65 years and older)
   3. Use in patients with kidney function disorders
   4. Use in patients with liver function disorders
   5. Instructions for taking the medicine
   6. Using a higher than recommended dose of Masultab
   7. Missing a dose of Masultab
   8. Stopping treatment with Masultab
9. Possible side effects
   1. Reporting side effects
10. How to store Masultab
11. Contents of the packaging and other information
    1. What Masultab contains
    2. What Masultab looks like and contents of the packaging
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:
    7. Date of last revision of the leaflet: 06.06.2024
    8. The following information is intended for healthcare professionals:

Leaflet included in the packaging: information for the user

Masultab, 50 mg, tablets

Masultab, 100 mg, tablets

Masultab, 200 mg, tablets

Masultab, 400 mg, tablets

Active substance: Amisulpridum
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you personally. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Masultab and what is it used for
• 2. Important information before taking Masultab
• 3. How to take Masultab
• 4. Possible side effects
• 5. How to store Masultab
• 6. Contents of the packaging and other information

1. What is Masultab and what is it used for

Amisulpride, the active substance of Masultab, is used to treat various forms of schizophrenia.
Masultab is indicated for the treatment of acute and chronic schizophrenic disorders with:

• positive symptoms of schizophrenia, especially with paranoid-hallucinatory syndrome (such as delusions, hallucinations, thought disorders),
• negative symptoms of schizophrenia (such as decreased drive, affective flattening, emotional withdrawal).

2. Important information before taking Masultab

When not to take Masultab:

• medicines that affect gastrointestinal motility (cisapride)
• medicines used in depression (sulpiride)
• sedatives (thioridazine)
• narcotic substitutes (methadone)
• intravenous antibiotics (erythromycin)
• certain antibiotics (sparfloxacin)
• medicines that improve blood circulation (vincamine)
• medicines used to treat protozoal infections (halofantrine, pentamidine)
• medicines used to treat fungal infections (imidazole)
• in children and adolescents under 14 years of age, Masultab should not be used.

Warnings and precautions

YoushouldexerciseparticularcautionwhentakingMasultabifyouhaveanyadditionalhealthconditions.BeforestartingtreatmentwithMasultab,youshouldconsultadoctor.
If the patient has any of the following diseases, the doctor will carefully monitor the use of Masultab and adjust the dosage individually:

• heart disease or blood vessel disease
• bone marrow damage
• severe kidney and liver disorders
• Parkinson's disease

Ifthepatientexperiencesacutealcoholpoisoning,sedatives,ormedicinesaffectingmentalfunctions.
In such a case, before starting treatment with Masultab, the doctor will treat the poisoning.
Elderlypatients(over65yearsold)
In the case of elderly patients, the doctor will carefully adjust the dose of Masultab to minimize the risk of low blood pressure or fatigue.
Ifthepatientexperiencesanyofthefollowingdisorders
If the patient experiences any of the following disorders during treatment, they should stop taking Masultab and immediately inform their doctor. The doctor will check if the patient has a very rare "malignant neuroleptic syndrome" (ang. malignant neuroleptic syndrome - MNS), which can lead to death, and will start appropriate treatment.
Ifthereareheartrhythmdisordersorchangesinlaboratorymeasurementsofheartrhythm(ECG).
Before starting treatment with Masultab, the doctor will check:

• if the patient has heart disease and coronary artery disease
• if there have been specific changes in the patient's family's ECG record (so-called long QT syndrome)
• if the patient is taking sedatives, tranquilizers, or antipsychotics (so-called neuroleptics), as their concurrent use with Masultab should be avoided.

Ifthereisariskofstroke
If the patient is at risk of stroke, the doctor will recommend taking Masultab with caution and will monitor the treatment course accordingly.
Ifthereisariskofbreastcancer
If the patient is at risk of breast cancer, the doctor will recommend taking Masultab with caution and will monitor the treatment course accordingly.
Ifthepatienthasdiabetes
Increased blood sugar levels have been observed during treatment with medicines like Masultab. If the patient has diabetes or risk factors for developing diabetes, the doctor will monitor blood sugar levels when starting treatment with Masultab.
Incaseofseizures
If the patient has or has had epilepsy in the past, they should inform their doctor, as Masultab may cause such symptoms. If necessary, the doctor will closely monitor the use of Masultab.
Ifthepatienthaskidneydisease
In the case of impaired kidney function, the doctor will reduce the dose accordingly.
Ifthepatientorafamilymemberhashadbloodclotsthepast
The use of antipsychotic medicines is associated with the occurrence of blood clots. The doctor will determine before starting treatment and during treatment if there are any risk factors for the development of venous thrombosis and will take preventive measures.
Incaseofsuddendiscontinuationoftreatment
Sudden discontinuation of high doses may cause withdrawal symptoms, such as nausea, vomiting, and drowsiness. Therefore, the doctor will recommend gradual, gradual discontinuation of Masultab.
Ifthepatientexperiencesunexplainedinfectionsorfever
In such cases, the doctor will order a blood test.
Ifthepatientexperiencesdecreasedvisionandpersistentheadache
Medicines like Masultab may increase prolactin levels (one of the hormones). During treatment with Masultab, cases of benign pituitary tumors (prolactinoma) have been observed (see "Possible side effects"). If the patient experiences decreased vision and headaches, which may be symptoms of a pituitary tumor, the doctor will order appropriate tests.
Liverdamage
Masultab may cause serious liver function disorders. The patient should contact their doctor immediately if they experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

Masultab and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The following medicines must not be taken at the same time as Masultab:

• medicines that can cause significant heart rhythm disorders (e.g., with the active substance quinidine, disopyramide, amiodarone, sotalol)
• Medicinal products containing the following active substances:
• levodopa, bromocriptine, ropinirole (in the treatment of Parkinson's disease)
• thioridazine, sulpiride (in the treatment of mental illnesses)
• sparfloxacin, erythromycin (intravenous) (some antibiotics)
• halofantrine, pentamidine (in the treatment of protozoal infections)
• imidazole (in the treatment of fungal infections)
• cisapride (a medicine used in gastrointestinal disorders)
• bepridil (in the treatment of heart pain)
• methadone (pharmacological replacement therapy)
• vincamine administered intravenously (a medicine that improves blood circulation).

The doctor will carefully monitor the use of Masultab in the case of concurrent use of the following medicines:

• medicines with a depressive effect, as strong drowsiness and drowsiness may occur, e.g., anesthetics, some painkillers, some antihistamines (used in allergic diseases or motion sickness), sedatives, tranquilizers, and antipsychotics, some medicines that lower blood pressure (active substance: clonidine and related substances)
• medicines that slow down the heart rate (such as diltiazem and verapamil, clonidine, guanfacine, digitalis glycosides)
• medicines that can cause potassium deficiency in the blood (diuretics, laxatives, active substances such as amphotericin (intravenous), glucocorticoids, tetracosactide)
• medicines used in the treatment of mental disorders (active substances such as pimozide, haloperidol, tricyclic antidepressants, lithium)
• the use of Masultab with the active substance clozapine may lead to an increase in the level of Masultab in the blood
• certain antimalarial medicines (e.g., with the active substance mefloquine).

Masultab and alcohol

Masultab may enhance the effect of alcohol on the nervous system. Therefore, the patient should avoid drinking alcohol while taking Masultab.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.
Pregnancy
Masultab is not recommended during pregnancy and in women of childbearing age who do not use effective contraception.
If the patient took Masultab during the last three months of pregnancy, the child may experience the following symptoms: restlessness, increased muscle tone, tremors, drowsiness, breathing difficulties, or feeding problems. If the child experiences any of these symptoms, the patient should contact their doctor.
Masultab passes through the placental barrier.
Breastfeeding
The patient should not breastfeed while taking Masultab. They should discuss with their doctor the best way to feed their child while taking Masultab.

Driving and operating machinery

Masultab may cause drowsiness and impaired vision, even if taken as recommended, and may affect reaction time to the extent that it impairs the ability to actively participate in traffic or operate machinery (see section 4 "Possible side effects"). This applies to a greater extent to the combination with alcohol and medicines with a depressive effect on the nervous system.

Masultab contains lactose and sodium

Masultab contains lactose monohydrate, a type of sugar. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Masultab

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
Tablets can be divided into equal doses.
For individual doses, the following tablet strengths are available: 50 mg, 100 mg, 200 mg, 400 mg
Unless the doctor prescribes otherwise, the recommended doses are as follows:
Negative symptoms of psychosis or symptoms of inhibition
Adults:
50-300 mg of amisulpride per day
Positive symptoms of psychosis
Adults:
400-800 mg of amisulpride per day. In individual cases, the maximum dose of amisulpride may be increased to 1200 mg per day.

Adolescents from 14 to 18 years old

There are limited data on the efficacy and safety of Masultab in adolescents from 14 to 18 years old, so its use cannot be recommended.
If there is an absolute indication, the dosage should be the same as for adults.

Elderly patients (65 years and older)

In elderly patients, the doctor will use Masultab with caution due to the risk of low blood pressure and depressive effects.

Use in patients with kidney function disorders

If the patient has reduced kidney function, the doctor may prescribe a lower dose.
Creatinine clearance of 30-60 mL/min: half the dose
Creatinine clearance of 10-30 mL/min: one-third of the dose.
If kidney function is even lower, the doctor will adjust the dose individually.

Use in patients with liver function disorders

Usually, no dose reduction is necessary

Instructions for taking the medicine

Oral administration.
The daily dose of Masultab up to 400 mg can be taken once.
In the case of higher daily doses, the doctor will recommend taking the medicine in two single doses.
Tablets should be swallowed whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water), regardless of meals.
The doctor will determine the individual dose and duration of treatment, depending on the patient's condition.

Using a higher than recommended dose of Masultab

Overdose symptoms may include drowsiness, somnolence, low blood pressure, tremors, and stiffness.
If a higher than recommended dose of Masultab is taken, the patient should immediately contact their doctor or go to the nearest hospital. They should take the medicine packaging with them so the doctor knows what medicine the patient took.
Information for the doctor on how to proceed in case of overdose can be found at the end of this leaflet.

Missing a dose of Masultab

The patient should not take a double dose to make up for a missed dose. They should continue treatment as usual.

Stopping treatment with Masultab

In the case of premature discontinuation of Masultab, the original symptoms may recur. Therefore, treatment should only be discontinued or terminated after consulting a doctor.
If the patient has any further doubts about the use of this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Masultab can cause side effects, although not everybody gets them.
The following side effects have been observed in controlled clinical trials and spontaneous reports. Note that in some cases, it is difficult to distinguish between side effects and symptoms of the underlying disease.
Very common:may affect more than 1 in 10 people

• Tremors, muscle tension, restricted movements, strong excitement, restlessness, movement disorders. (These disorders are mild when Masultab is dosed correctly and usually disappear completely after discontinuation of the medicine. The doctor will not discontinue Masultab treatment).

Common:may affect up to 1 in 10 people

• Increased prolactin levels in the blood may lead to temporary absence of menstruation, milk secretion, breast enlargement, breast tension, or erectile dysfunction (symptoms disappear after discontinuation of Masultab).
• Insomnia, anxiety, restlessness, sexual disorders.
• Neck spasms, eye muscle spasms, jaw spasms (these disorders disappear completely after administration of a specific treatment). The doctor will not discontinue Masultab treatment.
• Drowsiness, dizziness.
• Blurred vision.
• Low blood pressure.
• Constipation, nausea, vomiting, dry mouth.
• Weight gain

Uncommon:may affect up to 1 in 100 people

• Blood: decreased total white blood cell count (so-called leukopenia, neutropenia).
• Allergic reactions.
• Lipid metabolism disorders, increased cholesterol levels.
• Increased blood sugar levels (see also "Warnings and precautions").
• Confusion.
• During long-term treatment, involuntary movements of the tongue or face may occur; seizures
• Slow heart rate.
• High blood pressure.
• Stuffy nose, respiratory tract diseases.
• Decreased bone density, bone loss (so-called osteoporosis).
• Urinary retention.
• Increased liver enzyme activity (especially transaminases) in the blood.

Rare:may affect up to 1 in 1,000 people

• Blood: significant decrease in the number of certain white blood cells, increased susceptibility to infections, fever.
• Benign pituitary tumor (symptoms include decreased vision and headache) (see "Warnings and precautions").
• Decreased sodium levels in the blood, syndrome of inadequate ADH secretion (SIADH) (excessive water retention in the body with the production of overly diluted urine).
• "Malignant neuroleptic syndrome" with symptoms such as sudden fever, muscle stiffness, circulation disorders, and consciousness disorders (see "Warnings and precautions").
• Certain changes in the ECG (QT interval prolongation); heart rhythm disorders that can lead to ventricular fibrillation or cardiac arrest (potentially fatal) (see "Warnings and precautions").
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties.
• Skin: allergic, painful swelling of the skin and subcutaneous tissue, especially on the face; hives

Frequency not known:frequency cannot be estimated from the available data

• Restless legs syndrome (unpleasant sensation in the legs, which improves temporarily with movement and worsens at the end of the day)
• Liver cell damage
• Increased skin sensitivity to sunlight and ultraviolet radiation (UV)
• Withdrawal symptoms in newborns
• Falls due to side effects that affect balance, sometimes leading to fractures
• Rhabdomyolysis (muscle breakdown associated with muscle pain)
• Increased creatine phosphokinase activity (a blood value indicating muscle damage)

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Masultab

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Masultab contains

• The active substance of Masultab is amisulpride. Each tablet contains 50 mg, 100 mg, 200 mg, or 400 mg of amisulpride.
• Other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), hypromellose 2910 E5, microcrystalline cellulose PH-101, magnesium stearate.

What Masultab looks like and contents of the packaging

Masultab, 50 mg: white, round, flat tablets with a diameter of 7 mm.
Masultab, 100 mg: white, round, flat tablets with a diameter of 9.5 mm with the imprint "MC" on one side.
Masultab, 200 mg: white, round, flat tablets with a diameter of 11.5 mm with a dividing line on one side. The tablet can be divided into equal doses.
Masultab, 400 mg: white, biconvex tablets in the shape of a capsule, with a dividing line on both sides, measuring 19 mm x 10 mm. The tablet can be divided into equal doses.
Masultab, 50 mg, tablets: PVC/PE/PVDC/Aluminum or PVC/PVDC/Aluminum blisters, containing 12, 20, 30, 60, 90, or 100 tablets, in a cardboard box.
Masultab, 100/200/400 mg, tablets: PVC/PE/PVDC/Aluminum or PVC/PVDC/Aluminum blisters, containing 20, 30, 60, 90, or 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Medochemie Limited
Constantinoupoleos 1-10
3011 Limassol
Cyprus

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Amisu 50/100/200/400 mg-Tabletten
Poland: Masultab
Romania: Masultab 50/100/200/400 mg comprimate
Hungary: Talsian 50/100/200/400 mg tabletta

For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Phone: +48 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: 06.06.2024

The following information is intended for healthcare professionals:

Procedure in case of overdose
In case of acute overdose, the possibility of poisoning with several medicines should be considered.
Since amisulpride can only be dialyzed in small amounts, hemodialysis is not suitable for eliminating amisulpride. There is no specific antidote for amisulpride. In case of overdose, therefore, standard precautions should be taken: continuous monitoring of vital functions and ECG (risk of QT interval prolongation) until the patient recovers.
If severe extrapyramidal disorders occur, anticholinergic medicines should be administered.